A Study to Investigate Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Immunogenicity of RO7669330 in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

Launched by HOFFMANN-LA ROCHE · Apr 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called RO7669330 for people with geographic atrophy (GA), a condition that can occur due to age-related macular degeneration (AMD), which affects vision. The main goal of the study is to understand how safe the treatment is and how well it is tolerated by participants after they receive several doses of the medication through injections in the eye. The researchers will also look at how the medication moves through the body and how it influences the disease.

To participate in this trial, individuals must be between 20 and 88 years old and meet certain vision and health criteria. This includes having clear eye conditions that allow for good imaging and a specific level of vision quality. Participants should not have had certain previous eye treatments or conditions that could affect the study’s results. If eligible, participants can expect to receive the study medication and will be monitored closely for any side effects or changes in their vision throughout the study. It’s important to know that the trial is not yet recruiting participants, so there will be more information available as it progresses.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adequately clear ocular media, adequate pupillary dilation, and fixation to allow acquisition of good quality fundus imaging
• • GA that resides completely within the fundus autofluorescence (FAF) imaging field
• • Presence of hyperautofluorescence of either banded or diffuse pattern adjacent to the GA area on FAF
• * Study eye has early treatment of diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA) score as follows:
• • Part 1A: 19 to 48 letters inclusively
• • Part 1B: \> 19 letters
• • Part 2: ≥ 24 letters
• * Total GA lesion size must be as follows:
• • Parts 1A and 1B: ≥ 1.25 square millimeter (mm\^2) and ≤ 17.5 mm\^2 )
• • Part 2: ≥ 2.5 mm\^2 and ≤ 17.5 mm\^2
• Exclusion Criteria:
• Ocular Exclusion Criteria for the Study Eye:
• • Aphakic or pseudophakic with intraocular lens outside of the capsular bag
• • Previous laser photocoagulation or IVT anti-vascular endothelial growth factor (VEGF) for CNV, diabetic macular edema (DME), retinal vein occlusion (RVO), or proliferative diabetic retinopathy
• Ocular Exclusion Criteria for the Non-Study Eye:
• • - Non-functioning non-study eye, defined as either: BCVA of hand motion or worse and/or no physical presence of eye
• Ocular Exclusion Criteria for Both Eyes:
• • Macular atrophy in either eye due to causes other than AMD
• • Evidence of prior or active CNV
• • Prior treatment with any approved therapy for GA (Syfovre, Izervay) in either eye for Part 1A and Part 2. For Part 1B, prior treatment with any approved therapy for GA (Syfovre, Izervay) in the study eye ≤ 20 weeks prior to Day 1